Immunogenicity and safety profiles of a new MAV/06 strain varicella vaccine in healthy children: A multinational, multicenter, randomized, double-blinded, active-controlled phase III study.

Children Double blind Immunogenicity MAV/06 strain Multicenter Multinational Phase 3 Clinical trial Safety Varicella Vaccine

Journal

Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899

Informations de publication

Date de publication:
19 03 2021
Historique:
received: 23 08 2020
revised: 12 01 2021
accepted: 06 02 2021
pubmed: 26 2 2021
medline: 25 5 2021
entrez: 25 2 2021
Statut: ppublish

Résumé

Immunization is the most effective preventive strategy against varicella. While the Oka strain is commonly used for varicella vaccination worldwide, Korea widely uses the MAV/06 strain. A new live attenuated MAV/06 strain varicella vaccine (MG1111), which uses the new cell line Medical Research Council-5 for better viral propagation, was developed. MG1111 was approved by Korean health authorities. Here, we report the results of phase III, randomized, double-blind, multicenter study conducted in Korea and Thailand, which compared the immunogenicity and safety profiles of MG1111 versus the control vaccine, Varivax

Identifiants

pubmed: 33627245
pii: S0264-410X(21)00161-4
doi: 10.1016/j.vaccine.2021.02.013
pii:
doi:

Substances chimiques

Antibodies, Viral 0
Chickenpox Vaccine 0

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1758-1764

Informations de copyright

Copyright © 2021 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Ui Yoon Choi (UY)

Department of Pediatrics, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: uiyoon@catholic.ac.kr.

Ki Hwan Kim (KH)

Department of Pediatrics, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: poohwa99@gmail.com.

Jin Lee (J)

Department of Pediatrics, Hanil General Hospital, Seoul, Republic of Korea. Electronic address: pedleejin@naver.com.

Byung Wook Eun (BW)

Department of Pediatrics, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Republic of Korea. Electronic address: acet0125@hanmail.net.

Dong Ho Kim (DH)

Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea. Electronic address: kdh281920@gmail.com.

Sang Hyuk Ma (SH)

Department of Pediatrics, Changwon Fatima Hospital, Changwon, Republic of Korea. Electronic address: msh6517@hanmail.net.

Chun Soo Kim (CS)

Department of Pediatrics, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea. Electronic address: cskim@dsmc.or.kr.

Keswadee Lapphra (K)

Pediatric Infectious Disease Unit, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok Noi, Bangkok, Thailand. Electronic address: keswadee@gmail.com.

Auchara Tangsathapornpong (A)

Department of Pediatrics, Faculty of Medicine, Thammasat University, Klong Luang, Thailand. Electronic address: dr.auchara@yahoo.com.

Pope Kosalaraksa (P)

Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. Electronic address: pkosalaraksa@gmail.com.

Peninnah Oberdorfer (P)

Division of Pediatric Infectious Disease, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Electronic address: oberdorferp@gmail.com.

Hwang Min Kim (HM)

Department of Pediatrics, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Electronic address: khm9120@yonsei.ac.kr.

Son Moon Shin (SM)

Department of Pediatrics, Cheil General Hospital, Seoul, Republic of Korea. Electronic address: smshinmd@hanmail.net.

Jin Han Kang (JH)

Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: kjhan@catholic.ac.kr.

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Classifications MeSH